MAUDE Adverse Event Report: NUVASIVE INC NUVASIVE COHERE CERVICAL INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL

Model Number	4061427P2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Pain (1994); Respiratory Arrest (4461)
Date of Event	11/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product malfunction was alleged, the device is still in-situ and no radiographs were provided so the complaint can not be confirmed.Review of the reported event noted that during an anterior cervical discectomy fusion procedure the patient experienced hypercarbic respiratory failure requiring mechanical ventilation, additional postoperative swelling and pain requiring medication and dietary restrictions and consider severe dysphagia.The dysphagia is likely the body's response to surgical trauma (swelling) resulting from procedural requirements and or anatomical interference from the implant indicating patient selection, technique, implant selection and placement and or patient related factors as the root cause of this event.No device problem alleged or identified and no additional investigation required.Manufacturing review: no lot code information was provided so a complete manufacturing review could not be completed.Although review of ncmr records and similar events notes no non-conformances with respect to material type, treatments or dimensions that may have caused or contributed to this mode of failure."contraindications inadequate neuromuscular status (e.G.Paralysis, inadequate muscle strength).Patients with foreign body sensitivity." "potential adverse events and complications potential adverse effects resulting from use of the cohere cervical interbody fusion device include, but are not limited to, the following.Tissue reactions including macrophage and foreign body reactions adjacent to implants.Malalignment of anatomical structures (i.E.Loss of normal spinal contours or change in height).Pain, discomfort and abnormal sensations due to presence of the implant.Hematoma or thrombosis.Adverse effects may necessitate re-operation, revision or removal surgery.Implant removal should be followed by adequate postoperative management." "warnings, cautions and precautions.The cohere cervical interbody fusion device should be used only by those physicians who have been trained in the appropriate, specialized procedures.Knowledge of appropriate surgical techniques, instrumentation, proper selection and placement of implants and postoperative patient care and management are essential to a successful outcome.Correct selection of cohere cervical interbody fusion device components is extremely important.Carefully select the appropriate device size based on the needs of each individual patient." "patient selection information the surgeon is responsible for patient selection.The surgeon is responsible for understanding the appropriate indications and contraindications associated with the device and selecting the surgical procedures and techniques determined to be the best for each individual patient.Each surgeon must evaluate the appropriateness of the device and the procedure used to implant the device based on his/her own training experience." "information to obtain a surgical technique manual or should any information regarding the products or their uses be required, please contact your local representative or nuvasive directly at."(b)(4).
Event or Problem Description
The event was identified during a review of the cervical interbody pcmf study, the report identified that on (b)(6) 2024 a patient underwent a two level anterior cervical discectomy fusion procedure at c3/4 and c4/5 after which the patient was obtunded and given nalaxone and placed on bipap due to hypercarbic respiratory failure and transferred to icu.On (b)(6) 2024 she was evaluated by slp due to inability to swallow due to pain, coughing and choking requiring steroids to decrease swelling later discharged on full liquid diet and considered dysphagia.

• Brand Name: NUVASIVE COHERE CERVICAL INTERBODY SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
• Manufacturer (Section D): NUVASIVE INC; 7475 lusk blvd.; san diego CA 92121
• Manufacturer (Section G): NUVASIVE INC; 7475 lusk blvd.; san diego CA 92121
• Manufacturer Contact: whitney ginter ; 7475 lusk blvd.; san diego, CA 92121
• MDR Report Key: 20928188
• Report Number: 2031966-2024-00343
• Device Sequence Number: 5068694
• Product Code: ODP
• UDI-Device Identifier: 00887517056306
• UDI-Public: 887517056306
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K231735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 4061427P2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female